Eli Lilly and Co. and MacroGenics Inc. announced that the Protege Data Monitoring Committee (DMC), has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab.
The DMC, composed of independent experts in the fields of diabetes and biostatistics, concluded that the primary efficacy endpoint of the study was not met.
Following careful evaluation of the DMC’s recommendations for Protege, based on the lack of efficacy, the companies have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes: the Protege Encore Trial, a second Phase 3 trial of the same design as Protege, and the SUBCUE trial, a Phase 1b trial that is exploring the subcutaneous administration in patients with type 1 diabetes.
Teplizumab is an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.
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